A review of the challenges faced by industry and regulators with regards to REACH. REACH is the European Community Regulation on chemicals and their safe use. It deals with the Registration, Evaluation, Authorisation and Restriction of Chemical substances.
The entry into force of the REACH Regulation (EU Regulation No 1907/2006) has given significant impetus to non-ferrous metals science and to the development of tools, so as to be able to address its chemicals management requirements.
The need to maintain ‘access to the EU REACH market’ and the obligation to demonstrate ‘responsible care’ within a fixed timeframe have forced us to acquire a better understanding of the hazards and risks of our materials along their lifecycle, and across the exposures, uses and forms of the substances. Moreover, we had to take over the duty of ensuring the proper risk management of a substance, from cradle to grave, thereby going beyond the usual management area, e.g. a production site.
These obligations have prompted a huge effort to generate data since 2006; prompting industry to go back to existing knowledge – either publicly available or available as grey literature lying around in drawers – in an attempt to fill in the holes in the somewhat frightening ‘data gap analysis’ exercise. Strategies to make the best use of available data, to generate the missing information, and to develop methodologies and tools had to be agreed by groups of people sharing interests in one and the same substance, but who did not per se know each other. This all had to be done within a limited timeframe, which triggered some animated discussions on technical, cost- sharing and resource aspects.
Besides being an ‘information generator’, REACH has actually proven to be an incredible communication challenge, forcing the actors within the same supply chain to establish work and communication procedures, to exchange information on what constitutes the reality of the one and the other, and to ensure rapid and joint familiarisation with the subtleties of both the legal context of REACH and its implementation.
A significant number of metals and metal compounds had to be registered before the first REACH deadline (1 December 2010), which added considerable time pressure to these knowledge and communication challenges, resulting in some exhausted looks from consortia managers when we as Eurometaux – conveniently not registering – had to announce changes in guidance documents or in the tools.
All in all, the sector was able proudly to announce on 1 December that the non- ferrous metals industry had successfully reached the first REACH registration deadline, and even to add, in the same enthusiastic sentence, that we were aware that this first deadline was only a first step and that other challenges would follow.
The post-2010 registration recovery period has actually been short. Not only because the sector had to get down to the business of preparing the registration of lower tonnage substances, but also because some of the challenges that we had foreseen in December soon began to show their faces, during “post-registration debriefings” organised by industry and in meetings with the REACH enforcement regulatory authorities.
At this point, let me mention some of the challenges I see in the follow-up to registration at consortia, regulatory and site level. The focus will deliberately be on some of the technical challenges, which may in my opinion have an impact on the overall valuation of the data collection effort for registration.
To start with, the fact of having submitted a dossier for a substance on 1 December did not mean that the ‘R’(‘Registration’) page of REACH could be turned. It remains an active process, requiring further attention and resources from consortia – not always planned for at the time when the consortia were set up. There will be the necessary updates of the submitted files linked to for example new information becoming available or triggered by ECHA guidance changes and/or future reviews of REACH. In addition, some cosmetic updates of certain files are necessary. As a matter of fact, it should be realised that despite the general willingness and considerable efforts made, the dossiers submitted in 2010 have often only been “as good as possible” and could still have some weak spots when it comes to evaluating their completeness and defending a substance. Even in the non-ferrous metals sector, which has a solid tradition of co-operative work and is skilled at working together on multi-metallic risk assessment and classification projects, some differences among the dossiers can be detected. The approaches used are broadly similar, but the devil is lurking in the detail behind missing justifications, overly brief explanations, and sometimes inconsistencies between one compound and another. These flaws are a visible sign of the lack of time before the 2010 deadline, which did not enable all the metals to move together, at the same speed, towards complying with all the information requirements. Work has begun on addressing these shortcomings, but it will take time and will involve further resources that will have to be accounted for in consortia work programmes.
Within the last four years, industry has of necessity built up significant expertise in chemicals management and in ‘thinking in applied mode’. We have been driven by the need to find pragmatic solutions to conceptual issues. Some examples are:
a) how to deal with the aspects of ‘data-rich substances’ in a system designed for ‘data- poor’ and ‘safety factor’ approaches; b) the management of uncertainty versus precaution; and c) the consideration of aspects such as the massive form of the material or its ‘complex composition’. To overcome defaults in guidance documents or overly predictive estimations generated by models that did not take account of metal-specific aspects such as natural occurrence, certain biological mechanisms and essentiality, we had to go back to the sector data and develop metal-specific tools and approaches. These ‘solutions’ have required discussions, exchanges of information, workshops and significant volumes of ‘guidance notes’ spread throughout all the consortia. Interestingly, this essential move to pragmatism has enabled more industry people to be involved in the technical discussions, previously left up to the metals science professionals. Compared with three years ago, both in associations and companies, many more industry people are now used to finding their way around the jungle of acronyms used in metals science; they understand what risk assessment means and question the practical implications of classifications, Derived No Effect Levels (DNELs) and Exposure Scenarios. The situation naturally still leaves room for improvement, but overall, knowledge has increased and been brought right up to date.
Regulators and Industry Experts – Communication Challenges
What about the regulatory bodies’ experts? The setting up of REACH and its sequential implementation (focusing first on registration, then evaluation and finally authorisation) seem to have put certain regulators on hold to some extent. They had to prioritise the organisation of enforcement activities and resources for the further REACH processes. They also had to wait for the dossiers to become available, rather than being actively involved in brainstorming on technical issues in the dossiers as they may have been in the past. Regulators seem to have been somewhat out of the technical information circuit. On the other hand, several regulators seem to have made use of that registration time to better qualify what they are expecting from the REACH process and to identify the shortcomings of REACH that need to be addressed (e.g. combined effects).
All in all, the sector was able proudly to announce on 1 December that the non-ferrous metals industry had successfully reached the first REACH registration deadline, and even to add, in the same enthusiastic sentence, that we were aware that this first deadline was only a first step and that other challenges would follow.
There is an unfortunate timing incompatibility here: while we as industry are now awaiting their evaluation and would now be in a position to communicate on lessons learnt from registration, the REACH Regulators are now themselves faced with a huge amount of information, are subject to time pressure and are propelled towards ‘learning by doing’ within newly set-up committees, with new fields to address. ‘Breaking in’ the system and limited timeframes do not give regulators much opportunity either to familiarise themselves with the recent science and techniques built up for REACH by the various sectors, or to communicate on their registration period reflections.
This mismatch in schedules and priorities now leaves us with a kind of gulf between authorities and industry. For as long as both sides cannot meet and find means and dialogue on their respectively acquired expertise, this gulf could, in my opinion, adversely affect the discussions on the REACH dossiers and substances:
- First of all, despite the fact that we have never had as much information as now, the word ‘precautionary’ again seems to be actively part of the debates. Without becoming familiarised with this mass of data, how to handle the latter and their limitations, the ‘unknown’ remains a barrier, whatever the amount of information that may impel regulators to remain precautionary or not to fully consider the data collected.
- There is a normal human tendency to go back to what is known rather than diving into the unknown, particularly when there is pressure to deliver a certain amount of work. This can now be observed in the choice of some substances to be scrutinised through REACH processes: some of these have already been extensively and exhaustively discussed in earlier or other Chemical Management systems, and the question then arises as to whether this will enable the objective of REACH to be achieved, i.e. to streamline and improve the former legislative framework.
It is imperative to avoid discussions hampering the added value of the efforts made by both industry and regulators. Although the roles and rules for the REACH actors are well outlined in the legal text and guidance documents, this does not prevent emotion and/or frustration from bubbling up. I believe that it is even more vital to overcome this communication challenge when considering that it was not possible to solve all the technical issues in risk assessment and classification before December 2010. In the metals sector, we still have ahead of us a number of important questions to solve, related for example to the characteristics of “complex materials”, to testing difficulties and/or to data generation. We need a platform where we can discuss methodological proposals with experts involved in REACH committees and regulators involved in enforcement, so as to be able to propose the most appropriate safe use solutions to industry. Such platforms would allow us to discuss also forthcoming scientific challenges that are currently not covered by the scope of the REACH, such as the importance of diffuse emissions, mixture toxicity, etc.
Finally, we need to address the challenge of making the best use of the data generated at all levels, thinking beyond just the REACH-related steps. This is true for the EU, where companies are still exposed to legislation and regulatory ‘hints’ other than REACH. While efforts are being made at legislative level to solve some potential overlaps and to streamline the overall framework, responses should be found in the meantime to the practical questions that companies may pose: how to evaluate the REACH data, how to make the best use of the ‘core tools’ of REACH, such as Exposure Scenarios and DNELs, how these should be incorporated into day-to- day practice versus older references or tools proposed by other pieces of legislation. To address this could avoid filling cupboards once again with piles of unread papers.
Outside the EU, several jurisdictions are following with interest what is ongoing in the REACH scene, in order to both draw lessons and get information. This is an opportunity for some harmonisation of datasets and of technical aspects; and the OECD definitely plays a key role in this field.
REACH does not end with the successful submission of a completed registration dossier. This is only the beginning, in fact. A number of challenges and difficulties arise that could impact on the further process and its success. While these challenges seem to weigh preferentially either on the industry side or on the regulatory side, they concern all the REACH actors involved, and it is by solving them together that we shall guarantee the functioning and valuation of the efforts made up to now.
Violaine Verougstraete studied medicine and toxicology at the Catholic University of Louvain, did a DEA in Public Health and obtained her PhD in Public Health in 2005 from the Catholic University of Louvain (Belgium).
She worked as a researcher at the Industrial Toxicology and Occupational Medicine Unit of the Catholic University of Louvain for eight years. She collaborated in the EU Risk Assessment “Cadmium and Cadmium Oxide”. Since May 2005, she has been working for Eurometaux as Health and Alloys Manager. She is currently co-ordinating the scientific activities and projects of Eurometaux, such as for example the HERAG and MERAG (risk assessment) projects, classification projects, and human toxicology and ecotoxicology- related activities.